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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Hybrid HV Face Mask - Small
Innomed Technologies Inc
SM
In Commercial Distribution

  • M694HYB5915 ()
  • M694HYB5913 ()
  • M694HYB5911 ()
HYB591

  • CPAP/BPAP face mask, reusable
Hybrid NE Face Mask - Large
Innomed Technologies Inc
LG
In Commercial Distribution

  • M694HYB5755 ()
  • M694HYB5753 ()
  • M694HYB5751 ()
HYB575

  • CPAP/BPAP face mask, single-use
Hybrid NE Face Mask - Medium
Innomed Technologies Inc
MD
In Commercial Distribution

  • M694HYB5735 ()
  • M694HYB5733 ()
  • M694HYB5731 ()
HYB573

  • CPAP/BPAP face mask, single-use
Hybrid NE Face Mask - Small
Innomed Technologies Inc
SM
In Commercial Distribution

  • M694HYB5715 ()
  • M694HYB5713 ()
  • M694HYB5711 ()
HYB571

  • CPAP/BPAP face mask, single-use
Smoke Aspiration Tip
IMPLANTECH ASSOCIATES, INC.
SE-100
In Commercial Distribution

  • M724SE100102 ()
  • M724SE1001 ()
  • M724SE100252 ()
SE-100

  • Surgical plume evacuation system tube
Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / M-AMP / OPI / OXY / MTD
LUMIQUICK DIAGNOSTICS, INC.
07RD7065-39
In Commercial Distribution

  • M90107RD7065391 ()
  • M90107RD7065390 ()
  • M90107RD7065392 ()

  • Length: 75 Millimeter
07RD7065-39

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of oxycodone in human urine
LUMIQUICK DIAGNOSTICS, INC.
07RD7101
In Commercial Distribution

  • M90107RD71011 ()
  • M90107RD71010 ()
  • M90107RD71012 ()

  • Length: 75 Millimeter
07RD7101

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC/ OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7064-05
In Commercial Distribution

  • M90107RD7064051 ()
  • M90107RD7064050 ()
  • M90107RD7064052 ()

  • Length: 75 Millimeter
07RD7064-05

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Caretouch U-100 insulin syringe 31g 5/16" 8mm 0.5cc
Carelife (usa) Inc.
1
In Commercial Distribution

  • M992CTIS3150 ()
  • M992CTIS3151 ()
  • M992CTIS3153 ()
  • M992CTIS3155 ()
CTIS315

  • Insulin syringe/needle, basic
Caretouch U-100 insulin syringe 31g 5/16" 8mm 0.3cc
Carelife (usa) Inc.
1
In Commercial Distribution

  • M992CTIS3133 ()
  • M992CTIS3131 ()
  • M992CTIS3135 ()
  • M992CTIS3130 ()
CTIS313

  • Insulin syringe/needle, basic
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